Note: This document contains side effect information about amisulpride. Some dosage forms listed on this page may not apply to the brand name Barhemsys.

Applies to amisulpride: intravenous solution.

Serious side effects of Barhemsys

Along with its needed effects, amisulpride (the active ingredient contained in Barhemsys) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking amisulpride:

Less common

• Blurred vision
• chills
• confusion
• convulsions
• decreased urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• sweating
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Chest pain or discomfort
• cough or hoarseness
• fast, pounding, or irregular heartbeat or pulse
• fever with or without chills
• general feeling of tiredness or weakness
• hives, itching, or rash
• hoarseness
• irritation
• joint pain, stiffness or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• painful or difficult urination
• redness of the skin
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled swallowing
• unusual bleeding or bruising

Other side effects of Barhemsys

Some side effects of amisulpride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Pain at the injection site

Less common

• Full or bloated feeling
• pressure in the stomach
• swelling of the abdominal or stomach area

Incidence not known

• Anxiety
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• hyperventilation
• irritability
• nervousness
• restlessness
• shaking
• sleepiness or unusual drowsiness
• trouble sleeping

For Healthcare Professionals

Applies to amisulpride: intravenous solution.

General

IV: The most commonly reported side effects included infusion site pain, increased serum prolactin, chills, and hypokalemia.

Oral: The most commonly reported side effects included extrapyramidal disorder, insomnia, anxiety, and increased weight.^[Ref]

Nervous system

Acute dystonia was usually reversible without discontinuation of this drug when given concurrently with an antiparkinsonian agent. Acute dystonia included oculogyric crisis, spasm torticollis, and/or trismus.

Extrapyramidal symptoms (EPS) were usually mild at optimal doses, and were partially reversible without discontinuation of this drug when given concurrently with an antiparkinsonian agent. EPS included akathisia, dyskinesia, hypersalivation, hypokinesia, rigidity, and/or tremor.

Neuroleptic malignant syndrome was potentially fatal.

Tardive dyskinesia typically occurred after prolonged administration. Antiparkinsonian agents were ineffective, and/or possibly induced symptom aggravation.^[Ref]

IV:

Postmarketing reports: Dystonia, extrapyramidal disorder, neuroleptic malignant syndrome, seizure, somnolence

Oral:

Very common (10% or more): Extrapyramidal disorder (up to 11%)

Common (1% to 10%): Acute dystonia/dystonia, akathisia, dizziness, dyskinesia, headache, hypokinesia, somnolence, tremor

Uncommon (0.1% to 1%): Seizures, tardive dyskinesia

Rare (0.01% to 0.1%): Neuroleptic malignant syndrome

Frequency not reported: Restless legs syndrome with/without akathisia^[Ref]

Gastrointestinal

IV:

Common (1% to 10%): Abdominal distention

Oral:

Common (1% to 10%): Abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, hypersalivation, nausea, vomiting^[Ref]

Psychiatric

IV:

Postmarketing reports: Agitation, anxiety, confusional state, insomnia

Oral:

Common (1% to 10%): Aggressive reaction, agitation, anxiety, depression, insomnia, nervousness, orgasmic dysfunction, suicide attempt

Uncommon (0.1% to 1%): Confusion, sleep-related eating disorder, somnambulism/sleepwalking^[Ref]

Somnambulism included sleep-related eating disorder and other sleep-related behaviors.^[Ref]

Cardiovascular

Ventricular arrhythmias included Torsade de pointes and ventricular tachycardia, and may result in cardiac arrest, ventricular fibrillation, and/or sudden death.

Venous thromboembolism included deep vein thrombosis and fatal/nonfatal pulmonary embolism.^[Ref]

IV:

Common (1% to 10%): Procedural hypotension

Postmarketing reports: Bradycardia, hypotension, QT prolongation (by ECG), Torsade de pointes, ventricular tachycardia

Oral:

Common (1% to 10%): Hypertension/increased blood pressure, hypotension, postural hypotension, QT interval prolongation

Uncommon (0.1% to 1%): Bradycardia

Rare (0.01% to 0.1%): Cardiac arrest, deep vein thrombosis, Torsade de pointes, venous thromboembolism, ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia^[Ref]

Genitourinary

Oral:

Common (1% to 10%): Amenorrhea, galactorrhea, menstrual disorder, vaginitis

Uncommon (0.1% to 1%): Urinary retention

Frequency not reported: Breast pain, erectile dysfunction^[Ref]

Musculoskeletal

Oral:

Common (1% to 10%): Rigidity, spasm torticollis, trismus

Uncommon (0.1% to 1%): Osteopenia, osteoporosis^[Ref]

Dermatologic

IV:

Postmarketing reports: Urticaria

Oral:

Common (1% to 10%): Increased sweating, pruritus

Rare (0.01% to 0.1%): Urticaria

Frequency not reported: Photosensitivity reaction^[Ref]

Endocrine

IV:

Common (1% to 10%): Increased serum prolactin

Oral:

Common (1% to 10%): Reversible increase in plasma prolactin levels

Rare (0.01% to 0.1%): Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Frequency not reported: Gynecomastia^[Ref]

Female patients given a single, 5 to 10 mg IV dose over 1 to 2 minutes had serum prolactin levels that increased from a baseline of 10 ng/mL to 32 ng/mL; male patients given the same treatment had serum prolactin levels that increased from a baseline of 10 ng/mL to 19 ng/mL.

Reversible plasma prolactin level increases (upon drug discontinuation) resulted in amenorrhea, breast pain, erectile dysfunction, galactorrhea, and/or gynecomastia.^[Ref]

Other

IV:

Common (1% to 10%): Chills

Oral:

Common (1% to 10%): Fatigue

Rare (0.01% to 0.1%): Sudden death

Frequency not reported: Neonatal drug withdrawal syndrome^[Ref]

Ocular

Oral:

Common (1% to 10%): Blurred vision, oculogyric crisis^[Ref]

Local

IV:

Common (1% to 10%): Infusion site pain^[Ref]

Hepatic

IV:

Postmarketing reports: Increased liver enzymes

Oral:

Uncommon (0.1% to 1%): Hepatocellular injury, liver enzyme elevations, transaminase elevations^[Ref]

Respiratory

Oral:

Uncommon (0.1% to 1%): Aspiration pneumonia, nasal congestion

Rare (0.01% to 0.1%): Fatal pulmonary embolism, pulmonary embolism^[Ref]

Aspiration pneumonia usually occurred in combination with other antipsychotics and central nervous system depressants.^[Ref]

Hematologic

IV:

Postmarketing reports: Agranulocytosis

Oral:

Uncommon (0.1% to 1%): Leukopenia, neutropenia

Rare (0.01% to 0.1%): Agranulocytosis^[Ref]

Hypersensitivity

IV:

Postmarketing reports: Angioedema, hypersensitivity

Oral:

Uncommon (0.1% to 1%): Allergic reactions

Rare (0.01% to 0.1%): Angioedema^[Ref]

Oncologic

Oral:

Rare (0.01% to 0.1%): Benign pituitary tumor, prolactinoma^[Ref]

Metabolic

IV:

Common (1% to 10%): Hypokalemia

Oral:

Common (1% to 10%): Decreased weight, increased weight/weight gain

Uncommon (0.1% to 1%): Hypercholesterolemia, hyperglycemia, hypertriglyceridemia

Rare (0.01% to 0.1%): Hyponatremia^[Ref]